Herceptin

Medicinal product

(Invented) name

Herceptin

Active substance (s)

Trastuzumabas

Strength

600 mg

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FD01, trastuzumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2000-08-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

solution for injection in vial	5 ml
Trastuzumabas	600 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
58388	72551	1072551	flakonas	5 ml N1		Receptinis	EU/1/00/145/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-08-28	Registruotas